CEO John Plachetka says a bioequivalence study compares the aspirin component of his drug to an already marketed aspirin product. The FDA had requested that Pozen compare its candidate to a different aspirin component, to which Pozen obliged.

“We thought it was bioequivalent,” he says. “We still think it’s bioequivalent.”

But the FDA doesn’t agree. Plachetka has scheduled a July 9 call to discuss the findings with the FDA.

If the FDA says Pozen has to repeat the study, it will mean $1 million for a new trial. Having to conduct that study also means that a new drug application for the drug would be pushed to 2013.

“We’re continuing on with our progress because we think we have a winning case,” Plachetka says.